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Completed

NCT Number: NCT00652496

Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension

This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wenatchee, Washington, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ocular hypertension or glaucoma in both eyes
  • Require IOP-lowering therapy in each eye

Exclusion criteria

  • Uncontrolled systemic disease
  • Known allergy or hypersensitivity to bimatoprost

Treatment and study plan

Bimatoprost 0.01% ophthalmic solution

Drug

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

Bimatoprost 0.015% formulation 1 ophthalmic solution

Drug

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

Bimatoprost 0.015% formulation 2 ophthalmic solution

Drug

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

Bimatoprost 0.02% ophthalmic solution

Drug

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

Bimatoprost 0.03% ophthalmic solution

Drug

Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs

Other names: LUMIGAN®

Primary outcomes

  1. Intraocular pressure (IOP)

    Time frame: Day 5

Secondary outcomes

  1. Patient Comfort

    Time frame: Days 1-4

  2. Patient Satisfaction

    Time frame: Day 5

  3. Treatment Preference

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Apr 3, 2008
Registry last updated
Apr 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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